Generated Narrative: Composition compositione722f6782d3f34f86982e14386c8811dgg Language: es Profile: Composition (ePI) identifier: https://spor.ema.europa.eu/rmswi//yy status: Final type: Package Leaflet date: 2022-04-29 13:28:17+0000 author: Organization European Medicines Agency title: TEST PURPOSES ONLY - Dovato 50 mg/300 mg comprimidos recubiertos con película Attesters - Mode Time * Official 2022-04-29 13:28:17+0000
TEST PURPOSES ONLY - Dovato 50 mg/300 mg comprimidos recubiertos con película
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Package leaflet: Information for the user
Prospecto: información para el paciente Dovato 50 mg/300 mg comprimidos recubiertos con película dolutegravir/lamivudina Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted. Conserve este prospecto, ya que puede tener que volver a leerlo. Si tiene alguna duda, consulte a su médico o farmacéutico. Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles. Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.
Contenido del prospecto Qué es Dovato y para qué se utiliza Qué necesita saber antes de empezar a tomar Dovato Cómo tomar Dovato Posibles efectos adversos Conservación de Dovato Contenido del envase e información adicional
1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for
1. Qué es Dovato y para qué se utiliza Dovato es un medicamento que contiene dos principios activos usados para tratar la infección por el virus de la inmunodeficiencia humana (VIH): dolutegravir y lamivudina. Dolutegravir pertenece al grupo de medicamentos antirretrovirales llamados inhibidores de la integrasa (INI) y lamivudina pertenece a un grupo de medicamentos antirretrovirales denominados inhibidores de la transcriptasa inversa análogos de nucleósido (ITIAN).
2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película
2. Qué necesita saber antes de empezar a tomar Dovato No tome Dovato si es alérgico (hipersensible) a dolutegravir o lamivudina o a alguno de los demás componentes de este medicamento (incluidos en la sección 6) si está tomando un medicamento llamado fampridina (también conocido como dalfampridina; utilizado para tratar la esclerosis múltiple).
3. How to take Dovato 50 mg/300 mg comprimidos recubiertos con película
3. Cómo tomar Dovato Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico. La dosis recomendada de Dovato es un comprimido una vez al día. Trague el comprimido con un poco de líquido. Dovato se puede tomar con o sin alimentos.
4. Posibles efectos adversos Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran, por lo que es muy importante que le comente a su médico cualquier cambio en su estado de salud.
5. How to store Dovato 50 mg/300 mg comprimidos recubiertos con película
5. Conservación de Dovato Mantener este medicamento fuera de la vista y del alcance de los niños No utilice este medicamento después de la fecha de caducidad que aparece en la caja y el frasco después de CAD. La fecha de caducidad es el último día del mes que se indica. Este medicamento no requiere ninguna condición especial de conservación. Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.
6. Contents of the pack and other information
6. Contenido del envase e información adicional Composición de Dovato Los principios activos son dolutegravir y lamivudina. Cada comprimido contiene dolutegravir sódico equivalente a 50 mg de dolutegravir y 300 mg de lamivudina. Los demás componentes son celulosa microcristalina, carboximetilalmidón sódico, estearato de magnesio, manitol (E421), povidona (K29/32), fumarato estearilo de sodio, hipromelosa (E464), macrogol, dióxido de titanio (E171). Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido; esto es, esencialmente “exento de sodio”.
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Generated Narrative: Ingredient ingredient-for-dovato-sodiumstarchglycolate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/H8AV0SQX4D (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/19/1370/001 (use: official, ); status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/19/1370/001,https://www.who-umc.org/phpid#0x073AF2E5B92AE19E8B67635AFFB3D6CA; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#123456; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * sodium starch glycolate
Generated Narrative: Ingredient ingredient-for-dovato-magnesiumstearate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/70097M6I30 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/19/1370/001 (use: official, ); status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/19/1370/001,https://www.who-umc.org/phpid#0x073AF2E5B92AE19E8B67635AFFB3D6CA; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#123456; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * magnesium stearate
Generated Narrative: Ingredient ingredient-for-dovato-mannitol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/3OWL53L36A (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/19/1370/001 (use: official, ); status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/19/1370/001,https://www.who-umc.org/phpid#0x073AF2E5B92AE19E8B67635AFFB3D6CA; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#123456; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * mannitol
Generated Narrative: SubstanceDefinition substance-dolutegravirsodium Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//1Q1V9V5WYQ (use: official, ) version: 1 status: Active manufacturer: Organization GLAXO WELLCOME, S.A. MolecularWeights - Type Amount * exact 441.36 Structures - MolecularFormula * C20H18F2N305.Na Names - Name Type * (4R,12.ALPHA.S)-N-((2,4-DIFLUOROPHENYL)METHYL)-7-HYDROXY-4-METHYL-6,8-DIOXO-3,4,6,8,12,12.ALPHA.-HEXAHYDRO-2H-PYRIDO(1',2':4,5)PYRAZINO(2,1-.BETA.)(1,3)OXAZINE-9-CARBOXAMIDE Chemical Name
Generated Narrative: SubstanceDefinition substance-lamivudine Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//2T8Q726O95 (use: official, ) version: 1 status: Active manufacturer: Organization GLAXO WELLCOME, S.A. MolecularWeights - Type Amount * exact 229.26 Structures - MolecularFormula * C8H11N303S Names - Name Type * (-)-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)CYTOSINE Chemical Name
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Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES
Avda. Extremadura 3, 09400 Aranda De Duero
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Van Asch van Wijckstraat 55H Amersfoort NL
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Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL
Carretera De Martorell 41 61, Poligono Industrial Nord-Est
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Dovato 50 mg/300 mg film-coated tablets 30
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Medicinal product subject to medical prescription
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